Biofreeze

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Biofreeze
Generic name: MENTHOL
Manufacturer: Reckitt Benckiser LLC
Product type: HUMAN OTC DRUG
SPL set ID: 10a8face-47da-ebbe-e063-6294a90a42fe
SPL ID: 51b574d1-9ee5-b2aa-e063-6294a90a5a3f
Version: 8
Effective date: 2026-05-13
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:38:19

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Biofreeze	openfda.brand_name
generic name		MENTHOL	openfda.generic_name
manufacturer name		Reckitt Benckiser LLC	openfda.manufacturer_name
ndc	package	59316-870-10	openfda.package_ndc
ndc	product	59316-870	openfda.product_ndc
ndc11	package	59316087010	derived:openfda.package_ndc
rxcui		253020	openfda.rxcui
rxcui		2001133	openfda.rxcui
spl id		51b574d1-9ee5-b2aa-e063-6294a90a5a3f	id
spl set id		10a8face-47da-ebbe-e063-6294a90a42fe	set_id
unii		L7T10EIP3A	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings: For external use only When using this product: ■ use only as directed ■ avoid contact with the eyes or on mucous membranes ■ do not apply to wounds or damaged skin ■ do not apply to irritated skin or if excessive irritation develops ■ do not bandage tightly or use with heating pad or device Stop use and ask a doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur If pregnant or breastfeeding: Ask a health professional before use Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.